Do Regulatory Changes Seriously Affect the Medical Devices Industry? Evidence From the Czech Republic

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F61989100%3A27240%2F21%3A10248790" target="_blank" >RIV/61989100:27240/21:10248790 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/62690094:18450/21:50018087

Výsledek na webu

<a href="https://www.frontiersin.org/articles/10.3389/fpubh.2021.666453/full" target="_blank" >https://www.frontiersin.org/articles/10.3389/fpubh.2021.666453/full</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.3389/fpubh.2021.666453" target="_blank" >10.3389/fpubh.2021.666453</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Do Regulatory Changes Seriously Affect the Medical Devices Industry? Evidence From the Czech Republic

Popis výsledku v původním jazyce

Background: Within the EU, some of the challenges and perceived risks now facing medical device (MD) developers result from changes in the regulatory framework, emphasizing safety. Therefore, medical technology companies must adopt stricter quality assurance measures so that individual devices can be speedily tracked and retrieved in emergency situations. Objectives: We highlight the challenges and risks faced by the European medical devices industry, particularly those faced by SMEs in the Czech Republic. We address two important research questions: Q1. Do advantages from increased regulation outweigh the additional expenses? Q2. As many MD developers are SMEs, will the new regulatory regime result in some of those companies going out of business and therefore impede future innovation? Methods: The paper focuses on a single case study, with the situation and outcomes discussed in the context of the financial results of a further 50 medical device manufacturers marketing in the Czech Republic. Results: Our findings suggest that the new legislation will result in improved safety, facilitate product recalls, but the cost and administrative burden may be high. The evidence also indicates that some SMEs may be forced to diversify to &quot;non-medical&quot; products, with the inevitable loss of innovative MDs being made available to patients and healthcare providers. (C) Copyright (C) 2021 Maresova, Rezny, Peter, Hajek and Lefley.

Název v anglickém jazyce

Do Regulatory Changes Seriously Affect the Medical Devices Industry? Evidence From the Czech Republic

Popis výsledku anglicky

Background: Within the EU, some of the challenges and perceived risks now facing medical device (MD) developers result from changes in the regulatory framework, emphasizing safety. Therefore, medical technology companies must adopt stricter quality assurance measures so that individual devices can be speedily tracked and retrieved in emergency situations. Objectives: We highlight the challenges and risks faced by the European medical devices industry, particularly those faced by SMEs in the Czech Republic. We address two important research questions: Q1. Do advantages from increased regulation outweigh the additional expenses? Q2. As many MD developers are SMEs, will the new regulatory regime result in some of those companies going out of business and therefore impede future innovation? Methods: The paper focuses on a single case study, with the situation and outcomes discussed in the context of the financial results of a further 50 medical device manufacturers marketing in the Czech Republic. Results: Our findings suggest that the new legislation will result in improved safety, facilitate product recalls, but the cost and administrative burden may be high. The evidence also indicates that some SMEs may be forced to diversify to &quot;non-medical&quot; products, with the inevitable loss of innovative MDs being made available to patients and healthcare providers. (C) Copyright (C) 2021 Maresova, Rezny, Peter, Hajek and Lefley.

Druh

J_SC - Článek v periodiku v databázi SCOPUS

CEP obor

—

OECD FORD obor

20200 - Electrical engineering, Electronic engineering, Information engineering

Projekt

<a href="/cs/project/GA17-03037S" target="_blank" >GA17-03037S: Hodnocení investic do vývoje zdravotních prostředků</a><br>

Návaznosti

P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)

Rok uplatnění

2021

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Frontiers in Public Health

ISSN

2296-2565

e-ISSN

—

Svazek periodika

9

Číslo periodika v rámci svazku

duben 2021

Stát vydavatele periodika

CH - Švýcarská konfederace

Počet stran výsledku

13

Strana od-do

—

Kód UT WoS článku

—

EID výsledku v databázi Scopus

2-s2.0-85105911120